N/A
N=994
Boston Scientific Post Market Subcutaneous-Implantable Cardioverter Defibrillator (S-ICD) Registry
Tachycardia, Ventricular
Bottom Line
View on ClinicalTrials.gov: NCT01085435 ↗Enrolled (actual)
994
Serious AEs
20.2%
Results posted
Nov 2023
Primary outcome: Primary: Perioperative S-ICD Complication Free Rate — 983 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- S-ICD System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perioperative S-ICD Complication Free Rate |
983 | — |
| PRIMARY 360 Day S-ICD Complication Free Rate |
970 | — |
| PRIMARY Percentage of Inappropriate Shocks for Atrial Fibrillation (AF)/Supraventricular Tachycardia (SVT) |
29 | — |
Summary
The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System. In addition, analysis of resource utilization and costs will be performed to document treatment costs for periods defined by Registry endpoints. Protocol 90904928 restricts enrolment to patients over 18 years of age while protocol 90904925 allows all patients to be included.
Eligibility Criteria
Main study:
Inclusion Criteria
- Age >/= 18yrs
- Eligible for implantation of an S-ICD system per local clinical guidelines or currently implanted with an S-ICD system (Software (SW) version 1.59.0 or later)
- Willing and able to provide written informed consent or have informed consent as provided by a legal representative
Exclusion Criteria
- Participation in any other investigational study that may interfere with interpretation of the Registry results
- Incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing
- Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing
Extension Phase Sub-study:
Inclusion Criteria
- Subjects who are actively enrolled in the EFFORTLESS S-ICD Registry OR Subjects who completed the 5-year follow-up in the EFFORTLESS S-ICD Registry. All clinical events, spontaneous and induced episode data and system replacement or revision data since the last EFFORTLESS S-ICD Annual Follow-Up of the main study must be available in medical files or equivalent.
- Subjects who are actively implanted with an S-ICD pulse generator (SQ-RX, EMBLEM or EMBLEM MRI) and an S-ICD electrode (Q-TRAK or EMBLEM) or any other future commercial available versions
- Willing and able to provide written informed consent or have informed consent as provided by a legal representative and willing to participate in all testing and follow-ups as described the Sub-Study protocol
- Age 18 or above, and of legal age to give informed consent specific to national laws
Exclusion Criteria
- Subjects with device replacement from the S-ICD to a transvenous ICD
- Subjects with unipolar pacemakers or implanted devices that revert to unipolar pacing
- Subjects that are participating in any other investigational study that may interfere with interpretation of the Registry results, without the written approval of Boston Scientific
Data sourced from ClinicalTrials.gov (NCT01085435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.